PMID- 31697310
OWN - NLM
STAT- MEDLINE
DCOM- 20201218
LR  - 20211204
IS  - 2374-2445 (Electronic)
IS  - 2374-2437 (Print)
IS  - 2374-2437 (Linking)
VI  - 6
IP  - 2
DP  - 2020 Feb 1
TI  - Development and Use of the Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy 
      Axicabtagene Ciloleucel in Large B-Cell Lymphoma: A Review.
PG  - 281-290
LID - 10.1001/jamaoncol.2019.3869 [doi]
AB  - IMPORTANCE: Axicabtagene ciloleucel, an anti-CD19-CD28-CD3zeta chimeric antigen 
      receptor T-cell therapy, was the first US Food and Drug Administration-approved, 
      genetically engineered T-cell therapy for adults with relapsed or refractory 
      large B-cell lymphoma (LBCL) after 2 or more lines of systemic therapy. There has 
      not been a US Food and Drug Administration-approved product for these cancers in 
      more than 4 decades. OBSERVATIONS: Unlike traditional anticancer therapies, 
      axicabtagene ciloleucel is a patient-specific, live-cell product that has unique 
      requirements for manufacturing, shipping, and storage, as well as for its 
      administration and management of its adverse events. In addition, axicabtagene 
      ciloleucel has demonstrated efficacy in patients with refractory LBCL. This 
      review presents a timeline of the rapid clinical development of axicabtagene 
      ciloleucel from bench to bedside, highlights how axicabtagene ciloleucel 
      satisfies an unmet medical need for treatment of refractory LBCL, outlines the 
      logistics of the production process and administration of axicabtagene 
      ciloleucel, describes its mechanism of action, and summarizes the results of the 
      pivotal study. This review also provides a survey of adverse events, with 
      attention to the kinetics of their clinical presentation; discusses the 
      management of adverse events; and offers suggestions for appropriate patient 
      selection for safe administration of axicabtagene ciloleucel. CONCLUSIONS AND 
      RELEVANCE: The integration of axicabtagene ciloleucel therapy into 
      standard-of-care practice for relapsed/refractory LBCL is the beginning of a 
      paradigm shift in the treatment of patients with LBCL and is likely to lead to 
      improvements in their survival and curability. Timely referral to centers 
      offering the therapy is necessary for optimal patient outcomes.
FAU - Locke, Frederick L
AU  - Locke FL
AD  - Department of Blood and Marrow Transplant and Cellular Immunotherapy, H Lee 
      Moffitt Cancer Center & Research Institute, Tampa, Florida.
FAU - Go, William Y
AU  - Go WY
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Neelapu, Sattva S
AU  - Neelapu SS
AD  - The University of Texas MD Anderson Cancer Center, Houston, Texas.
LA  - eng
GR  - K23 CA201594/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Review
PL  - United States
TA  - JAMA Oncol
JT  - JAMA oncology
JID - 101652861
RN  - 0 (Antigens, CD19)
RN  - 0 (Biological Products)
RN  - 0 (CD19 molecule, human)
RN  - 0 (Receptors, Chimeric Antigen)
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
SB  - IM
MH  - Antigens, CD19/adverse effects/economics/immunology/*therapeutic use
MH  - Biological Products
MH  - Health Care Costs
MH  - Humans
MH  - Immunotherapy, Adoptive/adverse effects/economics
MH  - Lymphoma, Large B-Cell, Diffuse/economics/*therapy
MH  - *Receptors, Chimeric Antigen
MH  - Treatment Outcome
PMC - PMC7859915
MID - NIHMS1661398
EDAT- 2019/11/08 06:00
MHDA- 2020/12/19 06:00
PMCR- 2021/02/04
CRDT- 2019/11/08 06:00
PHST- 2019/11/08 06:00 [pubmed]
PHST- 2020/12/19 06:00 [medline]
PHST- 2019/11/08 06:00 [entrez]
PHST- 2021/02/04 00:00 [pmc-release]
AID - 2754748 [pii]
AID - 10.1001/jamaoncol.2019.3869 [doi]
PST - ppublish
SO  - JAMA Oncol. 2020 Feb 1;6(2):281-290. doi: 10.1001/jamaoncol.2019.3869.